FDA.report

Alcon

Primary DI
10380654204205
Brand
Alcon
Company
Alcon Laboratories, Inc.
Model
8065420420
Device description
Microsurgical Instrument THORNTON RETROBULAR NEEDLE 25GA X 19MM (1 1/2 IN)
Published
2020-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MXYCannula, ophthalmic, posterior capsular polishing, polyvinyl acetal

Product Code Classifications

CodeDeviceSpecialtyClass
MXYCannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl AcetalOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10380654204205PackageGS110In Commercial Distribution
00380654204208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065420420510380654204205
00380654204208003806542042083806542042080380654204208

GMDN Terms

TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-useA rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing or a basic handle (without controls). It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)862-5266web.masterus@alcon.com

Regulatory Flags

DUNS number
008018525
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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